MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S PYLORIC & DUODENAL COVERED STENT; PYLORIC & DUODENAL STENT

Model Number DCT2012BP

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

It was reported that after three cycles of chemotherapy, the two duodenal semss had migrated to the transverse colon and it was determined to remove them for avoiding perforation.It is hard to confirm the manufacturing history of the product because the serial number was not informed to us.Migration can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.Based on the description, "the physician commented that the obstruction seemed to be reduced by chemotherapy and it might cause migration," it is assumed that the stent migration occurred due to reduction of obstruction by chemotherapy, not stent malfunction.Through the user manual by taewoong, it is stated that, "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: migration." the suspected device is not registered in the u.S., and there will be continued to monitor the same, or similar customer complaints.

Event Description

An uncovered sems (22mm× 12 cm; next biomedical, korea) and a partially covered sems (dct2012bp) were deployed for the duodenal obstruction.After three cycles of chemotherapy, the two duodenal semss had migrated to the transverse colon, and it was determined to remove them for avoiding perforation.The physician commented that the obstruction seemed to be reduced by chemotherapy and it might cause migration.Influence by placing a covered stent in an uncovered stent is not identified.There were no patient complications as a result of this event.

• Brand Name: NITI-S PYLORIC & DUODENAL COVERED STENT
• Type of Device: PYLORIC & DUODENAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 10703039
• MDR Text Key: 214616004
• Report Number: 3003902943-2020-00086
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCT2012BP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1